Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial (THIAMINE-HF)
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|ClinicalTrials.gov Identifier: NCT03228030|
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : March 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Heart Failure With Reduced Ejection Fraction Thiamine Deficiency Congestive Heart Failure||Dietary Supplement: Thiamine Dietary Supplement: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial|
|Actual Study Start Date :||April 2, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||September 2020|
Experimental: Thiamine mononitrate 500mg po daily
3 months on thiamine, followed by 6 week washout period, and then 3 months on placebo arm
Dietary Supplement: Thiamine
Placebo Comparator: Placebo
3 months on placebo, followed by 6 week washout period, and then 3 months on thiamine
Dietary Supplement: Placebo
- Recruitment [ Time Frame: 11 months ]Number of participants recruited during the study period. This is a feasibility outcome.
- Refusal rate [ Time Frame: 11 months ]Number of eligible individuals refusing to participate in the research study. This is a feasibility outcome
- Retention rate [ Time Frame: 11 months ]Number of participants completing the study.
- Compliance rate [ Time Frame: 11 months ]Proportion of participants with >80% adherence to intervention.
- Left ventricular ejection fraction (LVEF) [ Time Frame: 3 months ]Echocardiogram measurement of left ventricular ejection fraction.
- Peak global longitudinal strain (%) [ Time Frame: 3 months ]Speckle tracking echocardiogram measurement of heart contractility. This is a more sensitive measurement of heart function than LVEF.
- NT-proBNP [ Time Frame: 3 months ]Heart failure biomarker
- New York Heart Association (NYHA) class [ Time Frame: 3 months ]Heart function symptom grading
- Quality of life [ Time Frame: 3 months ]Kansas City Cardiomyopathy Questionnaire
- HF hospitalizations [ Time Frame: 7.5 months ]Number of hospital stays >24h
- HF emergency room visits [ Time Frame: 7.5 months ]Number of hospital visits <24h
- Death due to cardiovascular causes [ Time Frame: 7.5 months ]As adjudicated by study committee
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228030
|Contact: Catherine Demers, MD MSc FRCPC||905-521-2100 ext firstname.lastname@example.org|
|Hamilton, Ontario, Canada, L8N3Z5|
|Contact: Catherine Demers, MD, MSc, FRCPC 905-521-2100 ext 73324 email@example.com|
|Principal Investigator:||Eric KC Wong, MD FRCPC||McMaster University|